Status:
TERMINATED
Combination of Chemoradiation With Immunotherapy in Inoperable œsophageal Cancer
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Inoperable œsophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main objective of the trial is to assess the feasibility and the safety of the addition of immunotherapy with PD-1 antibody nivolumab +/- CTLA-4 antibody ipilimumab to concomitant chemoradiation t...
Eligibility Criteria
Inclusion
- Histologically proven oesophageal squamous cell carcinoma or adenocarcinoma
- Both early stage and locally advanced tumor patients (according to TNM staging version 8):
- T1, N1-3, M0 after complete work-up
- T2, N0-3, M0 after complete work-up
- T3, N0-3, M0
- Patient eligible for definitive chemoradiation and not considered for primary surgery after multidisciplinary meeting decision or patient refuses to undergo surgery
- Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease
- At least one measurable lesion by CT scan or MRI based on RECIST version 1.1 with radiographic tumor assessment performed within 28 days prior to randomization
- Availability of adequate tissue in terms of quality and quantity for immunohistochemical staining for PDL-1
- WHO performance status 0 or 1
- Adequate organ function within 14 days prior to randomization
Exclusion
- Cancer of cervical oesophagus (15 to 19 cm from dental ridge)
- Known Her2 positive adenocarcinoma
- Weight loss \> 15 % over the last 3 months without improvement after nutritional support
- Patient with cardiac dysfunction e.g. symptomatic congestive heart failure, uncontrolled hypertension
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
- Any prior treatment for advanced disease including treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Live vaccines within 30 days prior to the first dose of study therapy. Examples of live vaccines include, but are not limited to the following: measles, mumps, rubella, chicken pox, yellow fever, H1N1 flu, rabies, BCG, and typhoid vaccine
- History of hypersensitivity to study drugs or any excipient (refer to SmPCs for ipilimumab, nivolumab, 5-FU and oxaliplatin)
- Current participation or treatment with an investigational agent or use of an investigational agent within 4 weeks of the first dose of study treatment
- Serious comorbidity or life expectancy less than one year
- Contraindication to chemoradiation therapy
- Treatment history of radiotherapy
- Child-Pugh B/C and patients with history of acute or chronic pancreatitis
- Patient with Type I diabetes mellitus, or skin disorders
- Known severe systemic autoimmune disease affecting the lungs or the bowel
- Known contraindication to CT scans with IV contrast
- Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 15 days prior to enrollment
- Active autoimmune disease that has required systemic treatment in past 2 years
- Autoimmune paraneoplastic syndrome requiring immunosuppressive or dedicated treatment
- History of any other hematologic or primary solid tumor malignancy, unless in remission for at least 5 years.
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03437200
Start Date
January 17 2019
End Date
October 7 2022
Last Update
February 21 2023
Active Locations (7)
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1
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
Paris, France, 75651
2
Institut Gustave Roussy
Villejuif, France, 94805
3
Hospital Del Mar
Barcelona, Spain, 08003
4
Institut Catala d'Oncologia - ICO Badalona - Hospital De Mataro
Barcelona, Spain, 08304